CN104689451B - A kind of vascular access device - Google Patents

Abstract

The invention discloses a kind of vascular access device, the vascular access device includes：Body, the body have the first tube chamber extended through it；Barrier film, the barrier film is arranged in first tube chamber, so as to which the first tube chamber is divided into portions of proximal and distal part, the first fluid seal that barrier film is formed between portions of proximal and distal part, barrier film also has the valve that fails being arranged between the portions of proximal and distal part；Pusher, the pusher is arranged in the portions of proximal of the first tube chamber, second fluid seal is arranged between the outer surface of pusher and the inner wall surface of the first tube chamber, pusher also has near-end, distal end and the second tube chamber extended between them, wherein, fluid communication is provided portions of proximal and distal part through that can fail valve by the distal advancement of pusher, so, the second tube chamber provides the pipeline between the nearside of the first tube chamber and distal part.

Description

A kind of vascular access device

The application is Chinese invention application number 201080012095.9 (international filing date 2010 year 2 month 11 days, international application Number PCT/US2010/023898), the division Shen of entitled " being used for the system and method that flushable conduit tube component is provided " Please.

Technical field

The present invention relates to infusion device, relates in particular in PeV (IV) conduit.Particularly, the present invention relates to one The flushable peripheral IV catheter component of kind, it has the feature that can selectively drive fluid flow through conduit component.

Background technology

Conduit is generally used for a variety of infusion therapies.For example, conduit be used for by fluid (such as physiological saline, multi-medicament and Complete parenteral nutrition) implantation in patient body, blood is extracted from the patient and monitors the more of the vascular system of patient Kind parameter.

Conduit or syringe needle are generally connected with catheter adapter, so as to which IV pipes are arranged on conduit.Therefore, will lead After pipe or syringe needle are placed in the vascular system of patient, catheter adapter is connected by a part for IV pipes with fluid source.In order to Prove that syringe needle and/or conduit are suitably disposed in blood vessel, clinician generally confirms have in the flash chamber of conduit tube component Blood " flash back ".

Once confirming conduit suitably-arranged, catheter adapter must be arranged in a part for IV pipes by clinician again. The processing needs clinician's manual block vein, to prevent undesirably being exposed in blood.The artificial of venous patient closes Plug needs clinician unhandily to keep pressure on the vein of patient, while catheter adapter is connected with IV pipes.

A kind of common but undesirable situation is permitted when IV pipes are arranged and be connected on catheter adapter by clinician Perhaps blood temporarily freely flows out from catheter adapter.Another general case is to be placed in by syringe needle or conduit in the vein of patient Catheter adapter is arranged on IV pipes before.Although this method can prevent from being undesirably exposed in blood, in IV Normal pressure in pipeline may also prevent desired flash back.

The complication associated with infusion therapy includes serious morbid state, or even dead.These complication may be due to blood Pipe enter device in stagnant fluid stream region or near extravascular region and cause.There is such region, wherein, Due to the barrier film in extravascular or the construction of valve system or the hydrodynamics in the region of extravascular, stream The flowing of body is restricted or is not present.Blood, air bubble or infusion medicament may be due to the fluid streams for limiting or being not present And capture in these Stagnation zones.When blood capture is in extravascular, bacterium may breed, and this may cause to feel Dye.When different pharmaceutical is inculcated to extravascular, or when extravascular is exposed in physical trauma, it is outside blood vessel The fluid stream of system may change, so as to which the air bubble of capture or residual drug to be released back into effective fluid passage of extravascular In.Serious complication may be caused by so discharging air bubble and residual drug to effective fluid passage extravascular.

The air bubble of release may block the fluid stream for flowing through extravascular, and prevent it from suitably working.It is tighter Weight, the air bubble of release and block blood stream, so as to cause tissue damage, even possibly into the vascular system of patient Apoplexy.In addition, residual drug may with the drug interaction inculcated, so as to cause precipitation in extravascular, and Prevent it from suitably working.Moreover, vascular system of the residual drug possibly into patient, and cause unexpected and/or do not wish The effect of prestige.

Therefore, this area needs a kind of conduit tube component, and it can be controlled and suitably flash back, while will not run into not The danger being hopefully exposed in blood.Moreover, this area it is also required to provide a kind of valve system in conduit tube component, it disappears Remove, the Stagnation zones that prevent or limit in vascular access device and extravascular, to provide more preferable flushing characteristics. Disclosed herein is such conduit tube component.

The content of the invention

In order to overcome above-mentioned limitation, the present invention relates to a kind of flushable peripheral IV catheter component, and it has and can selected Ground drives the feature of fluid flow through conduit component.The conduit tube component of the present invention generally includes conduit, the conduit and catheter adapter Connection.Conduit generally includes metal material, such as titanium, surgical steel or alloy, as known in the art.In some implementations Example in, polymeric catheter can be applied in combination with metal inducting device syringe needle, as known in the art with it is public.

In some embodiments of the invention, barrier film is arranged in the tube chamber of conduit tube component, to prevent or limit fluid Flow through catheter adapter.Barrier film generally includes flexible or semiflexible material, the material be adapted for exposure to blood, medicine and The other fluids typically encountered in implantation processing procedure.In certain embodiments, groove is provided on the inner surface of catheter adapter, Wherein, barrier film is placed in groove.Therefore, position of the barrier film in catheter adapter will be kept.

In certain embodiments of the present invention, the path (such as slit or aperture) closed or locally closed is also provided in In the stop surface of barrier film.The path allows fluid around barrier film and flows through catheter adapter.In certain embodiments, path is Slit, the slit positioned at intraluminal probe or the diaphragm activated device of catheter adapter before opening or driving by closing. Before opening or driving, slit prevents fluid from passing through catheter adapter.Therefore, in certain embodiments, multiple ventilation conduits It is placed between barrier film and groove, to allow air to flow through catheter adapter before slit is opened.Air-breather is prevented in conduit Normal pressure is accumulated in adapter, so that blood can flash back into the forward chamber of conduit and catheter adapter.

Diaphragm activated device generally comprises plastics or metal tube body, and the tubular bodies have end of probe and contact jaw.End of probe position Near the path of barrier film, contact jaw is located near the proximal open of catheter adapter.When probe inserts the near of catheter adapter When in side opening, the end of probe of diaphragm activated device is advanced through the path of barrier film.When probe and the contact surface of diaphragm activated device During contact, diaphragm activated device advances through catheter adapter along distal direction, and therefore, the end of probe of diaphragm activated device, which is opened, to be passed through The path of barrier film.Once opening, fluid can be flowed freely by conduit tube component.

Finally, abnormal fluid may be caused to flow in the intraluminal diaphragm activated device of catheter adapter, the abnormal fluid Flowing causes fluid being not intended to remain in a standstill and condense in conduit tube component.Therefore, in some embodiments of the invention, barrier film promotees Dynamic device also includes multiple flow deflectors and/or flowing turns to conduit, to be maintained at the suitable fluid stream in catheter adapter It is dynamic.

Brief description of the drawings

In order to be readily appreciated that the mode for obtaining above and other feature and advantage of the present invention, below with reference to the present invention's Specific embodiment more particularly introduces the present invention briefly introduced above, and these specific embodiments represent in the accompanying drawings.Accompanying drawing The exemplary embodiments of the present invention are show only, therefore are not regarded as to limit the scope of the present invention.

Fig. 1 is the sectional view of the inlying catheter of the flow control valve mechanism with prior art.

Fig. 2 is sectional view of Fig. 1 prior art inlying catheter after inducting device syringe needle is removed.

Fig. 3 is sectional view of Fig. 1 and 2 prior art inlying catheter after connector is inserted from vascular access device.

Fig. 4 is the perspective view according to the embodiment of the conduit tube component of the present invention.

Fig. 5 A are the view sub-anatomies according to the conduit tube component of the present invention.

Fig. 5 B are the perspective views according to the embodiment of the barrier film of the present invention.

Fig. 6 A are the sectional views of the interior lumen of catheter adapter, illustrate fluid stream, without according to the present invention's The diaphragm stimuli device of exemplary embodiments.

Fig. 6 B are the perspective views according to the embodiment of the diaphragm stimuli device of the present invention.

Fig. 6 C are existed according to the embodiment of the present invention, the diaphragm stimuli device being arranged in the interior lumen of catheter adapter Side view after excitation.

Fig. 6 D are the embodiments according to the present invention, the diaphragm stimuli device being arranged in the interior lumen of catheter adapter Side view, illustrate the fluid stream for flowing through catheter adapter.

Fig. 7 is the sectional view before excitation according to the present invention, the conduit tube component assembled.

Fig. 8 is according to the present invention, the sectional view of the conduit tube component assembled after actuation

Fig. 9 is the sectional view before excitation according to the present invention, the conduit tube component being assemblied in above syringe needle.

Figure 10 is the section view after inducting device syringe needle is removed according to the present invention, the conduit tube component being assemblied in above syringe needle Figure.

Figure 11 A to 11D are the sectional views of the barrier film with various features and structure according to an exemplary embodiment of the present invention.

Figure 12 be according to an exemplary embodiment of the present invention, the conduit tube component that is assemblied in above syringe needle cuing open after actuation View.

Figure 13 be according to an exemplary embodiment of the present invention, the conduit sheet with flow control valve mechanism and diaphragm stimuli device Sectional view of the body before excitation.

Figure 14 be according to an exemplary embodiment of the present invention, the conduit sheet with flow control valve mechanism and diaphragm stimuli device The sectional view of body after actuation.

Figure 15 be according to an exemplary embodiment of the present invention, the conduit sheet with flow control valve mechanism and diaphragm stimuli device Sectional view of the body before excitation.

Figure 16 is that catheter body shown in Figure 15, according to exemplary embodiments, with flow control valve mechanism is swashing Sectional view after encouraging.

Figure 17 be according to an exemplary embodiment of the present invention, the conduit sheet with flow control valve mechanism and diaphragm stimuli device Sectional view of the body before excitation.

Figure 18 is that catheter body shown in Figure 17, according to exemplary embodiments, with flow control valve mechanism is swashing Sectional view after encouraging.

Figure 19 be according to an exemplary embodiment of the present invention, the conduit sheet with flow control valve mechanism and diaphragm stimuli device Sectional view of the body before excitation.

Figure 20 is that catheter body shown in Figure 19, according to exemplary embodiments, with flow control valve mechanism is swashing Sectional view after encouraging.

Embodiment

Will be best understood by reference to the Figures the preferred embodiments of the present invention, in accompanying drawing, same reference numerals represent it is identical or Functionally similar element.Readily appreciate that, as shown in substantially described and accompanying drawing here, part of the invention can be arranged and set Count into a variety of different structures.Therefore, more detailed description below (as shown in the drawing) will be not intended to limit the model of application claims Enclose, and the simply representative of presently preferred embodiment of the invention.

Term " nearside " be used to representing device, during normal use near user and farthest away from the portion of patient Point.Term " distal side " be used for represent device, during normal use farthest away from using the device user and near The part of patient.What " excitation " of term valve system or barrier film was used to representing the valve opens or closes effect.

The example of the extravascular of prior art is introduced and represented in Fig. 1 to 3 in United States Patent (USP) No.7008404. As shown in fig. 1, inlying catheter has：Hollow tubing conductor body 1；Conduit 2, the conduit 2 are assemblied in the distal end for being arranged in catheter body 1 In the retainer 1b at place；Barrier film 3, the barrier film 3 are assemblied in the inside of catheter body 1；And hollow pusher 4, the hollow promotion Device 4 is slidably fitted within the inside of catheter body 1.Conduit 2, barrier film 3 and pusher 4 are with such order co-axially align.

Catheter body 1 has tubular in shape.Inner surface 1a is tapered towards distal end, has the diameter being gradually reduced.Preferably, Catheter body 1 is transparent or semitransparent material, to show inside, so as to check internal motion.For catheter body 1 Suitable material includes but is not limited to：Thermoplastic polymer resin, such as makrolon, polystyrene, polypropylene etc..

The press-fit of conduit 2 is fitted into tube holder 1b, and tube holder 1b is in its proximal end and the inside of catheter body 1 Connection.Preferably, lubricant coating provide on whole conduit or regional catheter 2, so as to reduce due to through skin or insertion blood Resistance caused by pipe.Suitable material for conduit 2 includes but is not limited to：Thermoplastic resin such as fluorinated ethylene propylene (FEP) (PEP), polytetrafluoroethylene (PTFE) (PTFE), polyurethane etc..Preferably, conduit 2 is formed by thermoplasticity and hydrophilic polyurethane, and this is poly- Urethane in existing physiological condition in patient body by softening.

Barrier film 3 is general tube shape, has near-end 8 and film portion 9, and the film portion 9 has the plane at distal end 11 Shape flat surface 10.Generally, barrier film 3 also includes single syringe needle slit 3a or valve opening, and the syringe needle slit 3a or valve opening are located at film section Divide 9 about at center, extend through film portion 9, in order to which inducting device syringe needle 5 penetrates barrier film 3.Syringe needle slit 3a's is relative Slit surface is designed to that the shape with inducting device syringe needle 5 during storage closely conforms to, and prevents fluid from removing inducting device Flow out during syringe needle 5 and afterwards, so as to be sealed when removing inducting device syringe needle 5.It is narrow when pusher 4 inserts through it Seam 3a expands and opened forward along distal direction, so as to provide fluid communication between the rear portion of conduit 2 and catheter body 1.Ring On the inner surface for the rear aperture that shape projection 3b is provided in barrier film 3, so that the convex shoulder 4c with the far-end in pusher 4 is engaged, So as to limit motion of the pusher 4 along proximal direction and prevent pusher 4 from being removed from barrier film 3.Multiple gap 3c be determined at every Between the periphery of film 3 and the inner surface 1a of catheter body 1.The distally and proximally space separated by barrier film 3 is by gap 3c and phase It is intercommunicated.Therefore, barrier film 3 smoothly slides, while air passes through gap 3c.

Pusher 4 is generally manufactured by rigidity and thermoplastic or similar material, and has the tube chamber extended through it.Push away Dynamic device 4 has：Barrel portion 4a；Tapered flanges 4b, tapered flanges 4b and barrel portion 4a rear portion near-end are connected；And convex shoulder 4c, convex shoulder 4c protrude from barrel portion 4a periphery.So, between barrel portion 4a and the inner surface 1a of catheter body 1 Produce annular space space.Barrel portion 4a distal front end is chamfer, in order to which it is penetrated into the slit 3a of barrier film 3, and should Barrel portion 4a is slideably supported by the annular protrusion 3b of barrier film 3.Tapered flanges 4b has cone-shaped inner surface, in order to syringe needle 5 insertions.Flange 4b periphery surface contacts with the inner surface 1a of catheter body 1, and for providing stability to pusher 4, and Keep the coaxial position relative to conduit 2.But, flange 4b periphery surface does not form Fluid Sealing with inner surface 1a.

Inlying catheter is prepared into be used with state as shown in Figure 1, wherein, the front end of syringe needle 5 is from the front end of conduit 2 Protrusion.In this state, syringe needle 5 penetrates barrier film 3, so as to provide the connection of water-stop between them, so as to anti-hemostasis Liquid is revealed.

Inlying catheter inserts in patient body in this state.Then, as shown in Figure 2, syringe needle 5 is taken out, and pipe 2 is kept In patient body.Barrier film 3 is when syringe needle 5 removes by keeping catheter body 1 to keep Fluid Sealing by annular protrusion 1e.Promote Device 4 is maintained at proximal position by annular protrusion 3b and convex shoulder 4c interaction.

Then, the connector 6 (such as luer adapter) of vascular access device inserts from the near-end of catheter body 1.Work as pressure When entering in catheter body 1, connector 6 promotes pusher 4 in its far-end.Therefore, pusher 4 is along distal direction to advancing slip It is dynamic, to press the slit 3a of barrier film 3 in its far-end and it is open, so as to which flow control valve is encouraged to open position Put.Then, barrier film 3 is pressed against the conical cavity 1c of catheter body 1 inner surface, and this causes travelling forward for pusher 4 to stop at Distal position as shown in Figure 3, so as to provide connection between conduit 2 and vascular access device.In the taper of catheter body 1 Surface 1a enables connector 6 smoothly to insert, and by by press-fit and the outer surface 6a and inner surface 1a of connector 6 it Between it is in sealing contact, to prevent fluid from the near-end of catheter body 1 to outward leakage.

However, it is to be understood that the valve system has the smaller void space region in catheter body 1, fluid can make Flowed into during in the smaller void space region, the region this generates reducing or without fluid stream.For example, using In, fluid can flow between flange 4b periphery surface and the inner surface 1a of catheter body 1, and flow into barrel portion 4a Periphery and inner surface 1a between void space 98 in.In addition, fluid can be flowed into void space 99, the void space 99 It is the gap 3c between the periphery of barrier film 3 and the inner surface 1a of catheter body 1.Exist in space/region 98 and 99 relatively low Fluid flow or no fluid flow make it difficult to then flush out and may flowed into during the use of conduit in these regions Any blood, medicine or bubble.

With reference to figure 4, conduit tube component 101 is illustrated in figure.Conduit tube component 101 generally includes conduit 12, and the conduit 12 is with leading The distal end 32 of pipe adapter 14 connects.Conduit 12 and catheter adapter 14 are integrated connection, so, the inside of catheter adapter 14 The tube chamber 18 of tube chamber 16 and conduit 12 is in fluid communication.Conduit 12 generally includes biocompatible material, and the material has enough Hardness, to bear to insert pressure associated in patient body with conduit.Conduit 12 includes metal material in certain embodiments, Such as titanium, stainless steel, nickel, molybdenum, surgical steel and their alloy.In other embodiments, conduit 12 includes rigid poly- Compound material, such as polyethylene.The tip portion 20 of conduit is usually disposed as including beveled surface 48.Beveled surface 48 is used to carry For opening in patient body, to allow conduit 12 to insert in the vascular system of patient.

The feature of conduit tube component can include the conduit tube component being used on syringe needle.It is for example, flexible or semiflexible poly- Compound conduit can be applied in combination with rigid inducting device syringe needle, so that conduit insertion is in patient body.Surgery can also be used Operation implantation catheter.

Once insertion is in patient body, conduit 12 and catheter adapter 14 provide fluid hose, in order to patient's supply stream Body and/or fluid is taken out from the patient, as needed for suitable implantation processing procedure.Accordingly, in a preferred embodiment, the He of conduit 12 The material selection of catheter adapter 14 is with biofluid and is inculcating compatible pharmaceutical usually used in processing procedure.In addition, In certain embodiments, a part for conduit 12 and/or catheter adapter 14 is arranged to tie with a part for intravenous pipe 40 Close and use, more easily to carry out supply of the fluid to patient or to remove fluid from the patient.

In certain embodiments, the near-end 22 of catheter adapter 14 includes flange 28.Flange 28 provides front surface, and this is just Surface may be arranged so that endovascular pipe or patient's pipeline 40 can be connected with conduit tube component 101.In certain embodiments, Flange 28 includes one group of screw thread 30.Screw thread 30 substantially provides and is arranged to consistently receive the supplementation group of screw thread 44, and the group includes A part for male Luer or pipe jointer 42.Pipe jointer 42 substantially in a fluid tight manner with patient's pipeline 40 End sections connect.In certain embodiments, the interior section of pipe jointer 42 stretches out, to provide detecting probe surface 46。

Detecting probe surface 46 is generally configured to consistently insert in the near-end 22 of catheter adapter 14.Conduit is inserted in probe 46 After in the near-end 22 of adapter 14, pipe jointer 42 is rotated into so that connector 42 and flange 28 are interlocked (by multigroup spiral shell Line 30 and 44).In the processing procedure of interlocking connector 42 and flange 28, before probe 46 is in the tube chamber 16 of catheter adapter 14 Proceed to insertion position (as shown in Figure 8).The insertion position of detecting probe surface 46 will drive conduit tube component 101, so that fluid Conduit 12 and catheter adapter 14 can be flowed through.Once pipe jointer 42 and catheter adapter 14 are installed, fluid can Patient is supplied by patient's pipeline 40 and insertion conduit 12.

Below with reference to Fig. 5 A, the decomposition diagram of conduit tube component 101 is illustrated in figure.In certain embodiments, conduit is fitted Orchestration 14 includes a variety of design features and part, to control and/or limit fluid flow through conduit component 101.For example, in this hair In some bright embodiments, barrier film 50 is located in the interior lumen 16 of catheter adapter 14.Barrier film 50 generally includes flexibility or half Flexible polymer plug, the external diameter of the plug are arranged to be placed at compatiblely on the inner surface 24 of catheter adapter 14 and formed Groove or conduit 60 in.In certain embodiments, barrier film 50 is tubular, has a stop surface 52, the stop surface 52 include every The distal end of film 50, and the barrier film also has opening 54, the opening 54 includes the near-end of barrier film 50.When being positioned in conduit 60, The interior lumen 16 of catheter adapter 14 is divided into anterior fluid chamber 62 and aft fluid chamber by the stop surface 52 of barrier film 50 64.Therefore, the presence control of barrier film 50 or limitation fluid passing through between front and rear fluid chamber 62 and 64.Specifically It is that the selected structure of the stop surface 52 of barrier film 50 substantially determines the energy of the interior lumen 16 of fluid flow through conduit adapter 14 Power.

For example, in certain embodiments, the stop surface 52 of barrier film 50 is arranged to include slit 56.The slit 56 is arranged to So that fluid selectively enters or flowed through stop surface 52.In certain embodiments, slit 56 is arranged to be maintained at closing, fluid The position of sealing, until advancing through slit 56 along distal direction 390 to be driven or open by diaphragm activated device 80. In some embodiments, stop surface 52 includes a slit 56.In other embodiments, stop surface 52 is changing into including multiple Slit 56 and 66, as shown in Figure 8.

For some infusion therapy technologies, it may be desirable to stream can be caused before barrier film 50 is driven by diaphragm activated device 80 Flow through barrier film 50 in body control ground.Therefore, in certain embodiments, slit 56 also includes leak 58.Leak 58 is positioned at stop In surface 52, and including opening diameter, the opening diameter is calculated as allowing liquid or air in front and rear chamber 62 and 64 Between control ground flowing.In certain embodiments, stop surface 52 is changing into including single leak 58.In other embodiments In, stop surface 52 is arranged to include multiple leaks.Further, in other embodiments, stop surface 52 does not include slit 56, but including at least one leak 58.For these embodiments, barrier film 50 generally includes elastomeric material, so, works as barrier film Actuator 80 along distal direction 390 advance when, the leading edge 92 of diaphragm activated device 80 contacts stop surface 52, and stretches leak 58, to provide bigger hole, so as to allow the air and/or fluid flow through conduit adapter 14 that increase.

Groove or conduit 60 (barrier film is placed in the groove or conduit 60) include the concave shaped portion of the inner surface 24 of catheter adapter 14 Point.The external diameter of barrier film 50 is usually disposed as securely resting within compatiblely in conduit 60.For example, in certain embodiments, barrier film 50 External diameter be chosen to the slightly less than diameter of conduit 60 and the diameter less times greater than interior lumen 16.Therefore, barrier film 50 is in conduit It is maintained at during the use of component 101 in conduit 60.

For some infusion therapy technologies, it may be desirable to carry out air flow between front and rear chamber 62 and 64. For example, for (embodiment includes the barrier film 50 with Fluid Sealing slit 56) in some embodiments, passing through diaphragm activated Device 80 prevents air from leading to back side chamber 64 from forward chamber 62 to open or drive before barrier film 50, as previously described.Therefore, when The conduit 12 of conduit tube component 101 is inserted in the vascular system of patient, normal pressure is formed in forward chamber 62, so as to prevent patient Blood properly flash back into catheter adapter 14.The flash back of observable is it is generally desirable to, catheter tip 20 for confirmation is correctly put In the vein of patient Yu.Therefore, some embodiments of the present invention include enabling to air in forward chamber 62 and back side chamber The feature or element flowed between 64, without driving barrier film 50 by diaphragm activated device 80.Therefore, some implementations of the invention Example provides the flash back of observable, as implantation processing procedure is generally desired.

For example, in certain embodiments, the stop surface 52 of barrier film 50 is changing into including leak 58, as previously described. In other embodiments, multiple ventilation conduits 70 are inserted in the inner surface 24 of barrier film 50 and catheter adapter 14.Conduit 70 of ventilating is logical Offer is crossed so that air discharges the normal pressure in forward chamber 62 around the import that barrier film 50 enters in back side chamber 64. In some embodiments, ventilation conduit 70 is formed by removing the part on the surface of conduit 60, multiple almost parallel so as to be formed Groove.

Except allow air flowed between front and rear chamber 62 and 64, ventilation conduit 70 can be arranged to by every Film actuator 80 allows fluid flow through conduit adapter 14 before driving or opening slit 56.In certain embodiments, air and/ Or the speed that is flowed between front and rear chamber 62 and 64 of fluid by the way that catheter adapter 14 is manufactured into including more or Less ventilation conduit 70 is adjusted.In other embodiments, air and/or fluid are in front and rear chamber 62 and 64 Between the speed that flows by the way that catheter adapter 14 is manufactured into including the ventilation conduit 70 with greater or lesser area of section To be adjusted.Therefore, in certain embodiments, air and/or fluid flow between front and rear chamber 62 and 64 Speed is cut by the way that catheter adapter 14 is manufactured into increase number ventilation conduit 70 or ventilation conduit 70 with bigger Face area and increase.On the contrary, in other embodiments, air and/or fluid flow between front and rear chamber 62 and 64 Speed by by catheter adapter 14 be manufactured into reduce number ventilate conduit 70 or ventilate conduit 70 with smaller Area of section and reduce.

With continued reference to Fig. 5 A, diaphragm activated device 80 includes probe-like structures, and the probe-like structures mainly load conduit adaptation In the back side chamber 64 of device 14.Diaphragm activated device 80 generally includes tubular bodies 82, and the tubular bodies 82 have distal end 84 and near-end 86.Pipe Body 82 includes rigidity or semi-rigid material, such as plastics or metal material.Tubular bodies 82 also include interior lumen 88, for side Just fluid and/or liquid flow through diaphragm activated device 80.

The distal end 84 of tubular bodies 82 is arranged to consistently insert in the opening 54 of barrier film 50.Distally 84 also include searching surface 90, the searching surface 90 passes through the position that the opening 54 of barrier film 50 is stretched near the stop surface 52 of barrier film 50, such as institute in Fig. 8 Show.When diaphragm activated device advances along distal direction 390 through catheter adapter 14, searching surface 90 through slit 56 and 66 or Person advances through leak 58.The advance of diaphragm activated device 80 through catheter adapter 14 is situated between in detail further in connection with Fig. 7 and 8 Continue.

Further, in other embodiments, barrier film 50 is coated with hydrophobic coat or polymer expansion coating, to repel Or anti-fluid flow crosses ventilation conduit 70.Hydrophobic coat is ordinarily selected to reduce the surface energy of barrier film 50 and/or adapter 14, To prevent blood from wicking to ventilation conduit 70.In certain embodiments, the surface of barrier film 50 or catheter adapter 14 coats There are poly-p-xylylene (polyxylylene) polymeric material, such as parylene.Parylene is chemistry Protective coating, there are good barrier properties for inorganic or organic fluid, strong acid, corrosive solution, gas and vapor. In some embodiments, parylene coating is applied on the outer surface of barrier film 50 by vapor deposition, in other implementations In example, poly-p-xylylene polymer coating is applied on ventilation conduit 70 by vapor deposition.

In certain embodiments, dehydrated polymer material be applied to barrier film 50 or catheter adapter 14 including air channel On the surface in road 70.Dehydrated polymer is ordinarily selected to expand or swell by contacting with fluid.Therefore, dehydrated polymer is worked as When swelling, ventilation conduit 70 will be flowed through to block or hinder by the polymer to swell.First, dehydrated polymer is generally in exposure Include more slim face before steam.But, when in steam, Polymer absorption steam, which increase polymer Type face, flow through air channel road 70 to block fluid.Therefore, by barrier film 50 and/or catheter adapter 14 coated with conjunction Suitable coating, air will be allowed to be flowed between front and rear chamber 62 and 64, but anti-fluid flow crosses ventilation conduit 70.

Below with reference to Fig. 5 B, the embodiment of barrier film 150 is illustrated in figure.In certain embodiments, the outer surface of barrier film 150 166 are changing into including multiple grooves 72.Groove 72 provides the path between front and rear chamber 62 and 64, air and/ Or fluid can flow through the path.Therefore, in certain embodiments, conduit 60 does not include ventilation conduit 70, but barrier film 150 Outer surface 166 be changing into suitable flowing be provided between front and rear chamber 62 and 64.

The blood pressure of patient substantially causes blood and air to flow through the He of barrier film 50 of conduit tube component 101 with given pace 150.Therefore, influenceed by the flow velocity of system by the effective hydraulic diameter of combination of whole flow passages.So, in some realities Apply in example, the hydraulic diameter of ventilation conduit 70 and/or groove 72 is changed, and flows through conduit tube component 101 to increased or decrease Speed.In other embodiments, the hydraulic diameter of ventilation conduit 70 and/or groove 72 reduces, so as to cause to flow through ventilation dress The flow put is significantly reduced or stopped.For controlling the control equation for the flow velocity for flowing through air-breather to be provided in equation 1, its In, BP is blood pressure, and A is the surface area of air-breather, and ó is the surface tension of blood, and P is the girth of air-breather.

Equation 1：BP (A)=ó (P)

Therefore, according to equation 1, when the girth of air-breather is smaller, air-breather will allow to ventilate, but anti-hemostasis Liquid stream is crossed (due to the of a relatively high surface tension ó of blood).But, when the girth increase of air-breather, in blood and lead to Surface tension between device of air reduces, so that blood can be revealed slowly through the air-breather and around barrier film, To provide suitable but also controllable flash back.Therefore, by adjusting multiple variables of equation 1, suitable flow will be obtained. Therefore, will be carried according to the size and/or number of the air-breather around barrier film, the design of conduit tube component around barrier film 50 or 150 For customization, controllable and predictable blood flow.In certain embodiments, it would be desirable to allow slow, controllable blood Liquid stream is moved, as the device for the visual detector being in for providing conduit in blood vessel, without being immediately exposed in blood It is dangerous.In other embodiments, it is desirable to only air is allowed to pass through the air-breather.

Below with reference to Fig. 6 A, the sectional view of the interior lumen of catheter adapter 14 is illustrated in figure.In certain embodiments, Catheter adapter 14 includes anterior fluid chamber 62 and aft fluid chamber 64, and they are flowed by narrow conduit or mouth 160 Body connects.As described above, in some embodiments is set, fluid passage 170 determines, therefore fluid 146 is from aft fluid chamber 64 Flow further downstream, flow through mouth 160 and enter anterior fluid chamber 62.Fluid passage 170 continue through anterior fluid chamber 62 and from Kaiyuan City end 32 enters conduit (not shown) or other downstream lines.When fluid 146 is full of the whole tube chamber of catheter adapter 14, Fluid passage 170 is substantially limited to the narrow gap of the kernel of section part by catheter adapter 14.Therefore, it is not narrow The fluid 146 of a part for fluid passage 170 is stagnated in dead band 156 or circulation.The fluid 146 captured in these dead bands is anti- Only it is sufficiently mixed with the fluid 146 in fluid passage 170.In certain embodiments, stagnating causes to increase chemical agent, body fluid And/or the local concentration of medicine, this may cause to precipitate, condense or supply dangerous high dose medicament.Therefore, in this hair Diaphragm activated device 80 is provided in some bright embodiments, the diaphragm activated device 80 has elimination in the tube chamber of catheter adapter 14 Dead band 156.

Below with reference to Fig. 6 B, the perspective view of diaphragm activated device 80 is illustrated in figure.In certain embodiments, tubular bodies 82 Distally 84 include the first diameter 100, and first diameter 100 is less than the Second bobbin diameter 102 of near-end 86.Narrower distal end 84 is arranged to Consistently insert in the opening 54 of barrier film 50, while broader near-end 86 is arranged to consistently be placed in the rear portion of catheter adapter 14 In chamber 64.In certain embodiments, diaphragm activated device also includes conical midportion 104, to connect distal end 84 and near-end 86。

In certain embodiments, the near-end 86 of diaphragm activated device 80 also includes keeping spring 110.The holding spring 110 is big The outside biased sections for including tubular bodies 82 are caused, are arranged to consistently engage with diaphragm activated device retention groove 68, such as Fig. 5 A and 7-8 It is shown.Keeping tube chamber 16 of the interaction limitation diaphragm activated device 80 between spring 110 and groove 68 in catheter adapter 14 Interior transverse movement.Therefore, the width of retention groove 68 determines or limited diaphragm activated device 80 and run in catheter adapter 14 Distance.In addition, the interaction between holding spring 110 and groove 68 will prevent diaphragm activated device 80 from catheter adapter 14 Upper dismounting.In certain embodiments, diaphragm activated device 80 includes multiple holding springs 110, and in other embodiments, barrier film promotees Dynamic device 80 includes single holding spring 110.

In certain embodiments, diaphragm activated device 80 also includes being used to guide fluid stream or fluid stream is turned to and is allowed to The circular and/or features by diaphragm activated device 80.Fluid turns to may be for preventing fluid in the dead of diaphragm activated device 80 It is important to stagnate in the tube chamber 16 of area 156 and/or catheter adapter 14 or condense and cause for obstruction.Led in addition, flowing through The stagnation of the fluid of tube assembly 101 may cause in catheter adapter 14 and/or diaphragm activated device 80, undesirable medicine Concentration buildup, as it was previously stated, undesirable high concentration may cause the futile treatment for causing serious side effects (including death).Cause This, in certain embodiments, diaphragm activated device 80 is changing into turns to conduit 130 including flow deflector 120 and flowing, to carry For the flushable system of conduit tube component 101.

Flow deflector 120 generally includes the inwardly or outwardly sloping portion of the outer surface of diaphragm activated device 80.Flowing is inclined Turn device 120 to be positioned to be protruding to through in the flow passage of catheter adapter 14.Therefore, when fluid and flow deflector 120 connect When touching, fluid flow passages will be disturbed.Such interference causes the interior lumen 88 for flowing through diaphragm activated device 80 and in barrier film The fluid stream flowed between the outer surface of actuator 80 and the inner surface 24 of catheter adapter 14 changes direction.In some embodiments In, keep spring 110 to also serve as flow deflector 120.

Additionally provide flowing and turn to conduit 130, so as in the tube chamber and diaphragm activated device 80 of catheter adapter 16 Fluid communication is carried out between interior lumen 88.Therefore, flowing, which turns to conduit 130, prevents fluid in the inner surface of catheter adapter 14 Stagnate and/or condense between 24 and the outer surface of diaphragm activated device 80.In certain embodiments, flowing turns to conduit 130 and included Window or opening in the surface of tubular bodies 82.In other embodiments, flowing, which turns to conduit 130, also includes tabs or inclination Surface, further to guide fluid flow past conduit 130.

The near-end 86 of diaphragm activated device 80 also includes contact surface 140.Contacting surface 140 includes diaphragm activated device 80 most Proximal part, and be positioned at close to the proximal open 26 of catheter adapter 14 in the back side chamber 64 of catheter adapter 14, it is as follows Shown in the Fig. 7 of face.

Below with reference to Fig. 6 C, the embodiment of diaphragm activated device 180 is expressed as the tube chamber positioned at catheter adapter 14 (with dotted line Represent) in.In certain embodiments, diaphragm activated device 180 is arranged to include a variety of re-circulation features.For example, in some realities Apply in example, diaphragm activated device 180 includes multiple air-breathers 200, and these air-breathers 200 are arranged so that fluid is logical from flowing Road 170 is diverted to dead band 156.Therefore, when fluid flows into and through diaphragm activated device 180, the stream in diaphragm activated device 180 Body passes through air-breather 200 and the dead band entered between the inner wall surface of the outer surface of actuator 180 and catheter adapter 14 In 156.The fluid of steering is mutually mixed with the fluid in dead band 156, so as to from the rinse fluid art of dead band 156, and is therefore prevented stagnant Stream and/or excessively concentration, as previously described.

In certain embodiments, diaphragm activated device 180 is further change in into including rinsing fin 220.It is logical to rinse fin 220 Often include dead band outer surface, stretching between the inner wall surface of actuator 180 and catheter adapter 14 of actuator 180 Vertical extension in 156.Rinsing fin 220 is used to cause the fluid in fluid passage 170 to turn to and redirect till death In area 156.Therefore, the fluid in dead band 156 is mutually mixed with the fluid in flow passage 170, to prevent fluid from existing Remain in a standstill in catheter adapter 14 and/or excessively concentrate.

Finally, in certain embodiments, flowing turns to conduit 130 and is changing into including flow deflector 230.Flow deflector 230 include fluid deflector that flowing turns to conduit 130, being located so that in flow passage 170 to anterior fluid chamber 62 Slanted distal surfaces in dead band 156.Therefore, when fluid 146 flows through diaphragm activated device 180, a part for fluid, which turns to, leads to Excessively stream turn enters in dead band 156 to conduit 130 and by flow deflector 230, as shown in figure 6d.

With continued reference to Fig. 6 D, the diaphragm activated device 180 of section view is positioned in the catheter adapter 14 of section view.As it was previously stated, Recirculating feature can add on the near-end 86 and distal end 186 of diaphragm activated device 180.In certain embodiments, barrier film promotees The near-end 86 of dynamic device 180 is changing into including bending window feature 240, and the window feature 240 causes fluid stream 246 to redirect to In the dead band 156 of aft fluid chamber 64.Therefore, the curved surface 242 of window feature 240 is independent and/or is followed again with other Ring combinations of features the fluid in dead band 156 is promoted to be mutually mixed, to prevent fluid viscous flow and mistake in catheter adapter 14 Degree concentration.

In certain embodiments, feature location is recirculated into symmetrical structure, to cause optimal flushing.In other implementations In example, feature location is recirculated into dissymmetrical structure, to cause optimal flushing.Finally, in certain embodiments, follow again Ring feature and added diffusion, circulation and the re-circulation combinations of features of diaphragm activated device 180 use, to help diaphragm activated device 180 fluid flushing ability.According to preceding description, the additional surface of diaphragm activated device 180 can be changing into be increased when needed Or reduce flow efficiency, such that the fluid in diaphragm activated device 180 is mixed and rinsed.

Below with reference to Fig. 7, the conduit tube component 101 that assembling is illustrated in figure passes through the driving of diaphragm activated device 80 in barrier film 50 Preceding sectional view.Before driving, diaphragm activated device 80 is entirely positioned in the aft fluid chamber 64 of catheter adapter 14.Separately Outside, keep spring 110 to be bonded in retention groove 68, and be positioned within the near proximal ends of groove 68.The contact of diaphragm activated device 80 Surface 140 is positioned near the opening 26 of catheter adapter 14, so, the proximal open 142 of diaphragm activated device 80 with conduit In the almost parallel plane of the planes of adapters openings 26.Finally, the holding spring 110 outwards biased is bonded at the surface of groove 68 On, so that diaphragm activated device 80 is maintained at the non-activation point in catheter adapter 14.

Below with reference to Fig. 8, the cuing open after barrier film 50 is driven by diaphragm activated device 80 of conduit tube component 101 is illustrated in figure View.By connector 42 insert catheter adapter 14 proximal open 26 in, the probe portion 46 of connector 42 with every The contact surface 140 of film actuator 80 contacts.When connector 42 is further inserted into the proximal open 26 of catheter adapter 14, Diaphragm activated device 80 advances along distal direction 390.When connector 42 is advanced further into proximal open 26, diaphragm activated device 80 searching surface 90 passes through the stop surface 52 of barrier film 50.Therefore, the searching surface 90 of diaphragm activated device 80 is located at anterior chamber In room 62, so as to provide the fluid passage through barrier film 50.

In certain embodiments, conduit tube component 101 is arranged so that diaphragm activated device 80 can be in connector 42 from conduit The position completely in back side chamber 64 is back to after being taken out in adapter 14.Therefore, when connector 46 is from conduit tube component 101 When middle taking-up or dismounting, it is re-closing off by the fluid passage of barrier film 50.In certain embodiments, spring 110 is kept to be arranged to Curved inwardly by the contact between the contact surface 140 of diaphragm activated device 80 and the probe 46 of connector 52.Work as holding When spring 110 curves inwardly, the searching surface 90 of diaphragm activated device 80 temporarily advances along distal direction 390, is opened to bias Slit 66 and 56 or leak 58.When the contact between probe 46 and contact surface 140 stops, spring 110 is kept to return It is back to its slack position.The slack position causes the searching surface 90 of diaphragm activated device 80 to be retracted from stop surface 52, so as to Allow to close slit 66 and 56.

Below with reference to Fig. 9, the sectional view of the conduit tube component 300 including inducting device syringe needle 350 is illustrated in figure.Syringe needle 350 Near-end 352 can be connected with needle hub (not shown) or plug-in package (not shown), in order to which user inserted in conduit Syringe needle 350 is held and operated in journey.In order to clearly show that, the remainder of needle assembly has been eliminated.

Before driving, diaphragm activated device 380 is entirely located in the back side chamber 364 of catheter adapter 314.Provide and wear The path of the interior lumen 316 of actuator 380 is crossed, to allow inducting device syringe needle 350 to pass through.Wear the center section of syringe needle 350 Barrier film 356 is crossed, and continues across forward chamber 362 and enters flexible conduit 312.The tip portion (not shown) of syringe needle 350 exceedes The tip portion (not shown) extension of conduit 312, so, needle tip can be used for the vascular system into patient.

The slit 366 of barrier film 356 is opened by inducting device syringe needle 350 to bias.In certain embodiments, seal is formed Between the outer surface of syringe needle 350 and slit 366.It is therefore prevented that fluid and air stream by syringe needle 350 and slit 366 it Between interface and bypass barrier film.In certain embodiments, conduit or path are provided between slit 366 and syringe needle 350, so as to Allow controlled leakage between the two elements or flowing.

In other embodiments, lubricant (such as water-free lubrication agent) is applied to the friendship between syringe needle 350 and slit 366 On interface, further to eliminate the leakage of the possibility of fluid and/or air.Water-free lubrication agent can also be prevented advantageously to slit Tear or other damages, this is torn or other damages may produce after inserting conduit when syringe needle takes out from conduit tube component It is raw.Water-free lubrication agent can also be advantageous to after syringe needle 350 is taken out so that two halves slit 366 suitably aligns.Nothing can also be used The non-limiting examples of water lubrication agent include the known anhydrous material for being based on polytetrafluoroethylene (PTFE) (Teflon), such as：Endura, come from Endura Coating Co.；A20, E-20,1000-S20, FEP Green, PTFE and X-40, from Tiodize； Cammie2000, from AE Yale；21845, from Ladd research；MS122-22、MS 122DF、MS-143DF、MS- 122V, MS-122VM, MS143V, MS-136W, MS-145W, U0316A2, U0316B2, MS-123, MS-125, MS-322 and MS-324, from Miller-Stepheson；And 633T2, from Otto Bock.It is a variety of to be based on non-polytetrafluoroethylene (PTFE) (Teflon) water-free lubrication agent types of material includes：Dylyn, from ART；Nyebar、Diamonex、NiLAD、TIDLN、 Kiss-Cote, titanium oxide；Fluocad Fluorochemical Coating FC-722, from 3M；Permacote, come from Dupont；Plasma Tech 1633, from Plasma Tech, Inc.；And silicone jet.

In certain embodiments, extend the distal end 384 of diaphragm activated device 380 so that contact surface 340 is positioned to more lean on The proximal open 326 of nearly catheter adapter 314.Therefore, have the connector (not shown) for shortening probe portion can be with contacting Surface 340 fully contacts, so that distal end 384 is advanced through barrier film 356.In other embodiments, diaphragm activated device 380 Distally 384 are arranged to include internal diameter, the external diameter substantially the same size of the internal diameter and inducting device syringe needle 350.Therefore, distal end 384 Internal diameter is arranged to allow syringe needle 350 by while being maintained at the outer surface of syringe needle 350 and the distal end 384 of diaphragm activated device 380 Minimal tolerance 382 between inner surface.The minimal tolerance 382 provides seal, so as to which anti-Hemostatic Oral Liquid is in syringe needle 350 and barrier film Leakage or flowing between actuator 380, while syringe needle 350 is exited from conduit tube component 300.

In certain embodiments, conversion groove 368 is provided in back side chamber 364.Conversion groove 368 is generally comprised with determination The annular notch of length 370.Conversion groove 368, which is also configured to receive, rinses fin 320 so that rinses fin 320 and is maintained at groove 368 It is interior.Therefore, length 370 represents the maximum transversal distance that diaphragm activated device 380 can be run in back side chamber 364.At some In embodiment, the near-end of groove 368 is determined by annular ridge 372.In other embodiments, the distal end of groove 368 is by the second annular ridge 374 determine.Further, in other embodiments, the second annular ridge 374 forms the near-end of barrier film conduit 60.

Below with reference to Figure 10, sectional view of the conduit tube component 300 after inducting device syringe needle 350 is taken out is illustrated in figure.It is logical Taking-up inducting device syringe needle 350 is crossed, the slit 366 of barrier film 356 no longer biases opening, therefore is re-closing off and seals, to prevent Fluid and/or air flow through slit 366.As it was previously stated, in certain embodiments, slit 366 includes leak (not shown), with Just the control between front and rear chamber 362 and 364 is allowed to flow.In other embodiments, multiple ventilation conduits 70 are set It is placed between the outer surface of barrier film 356 and barrier film conduit 60.

Below with reference to Figure 11 A to 11D, barrier film 356 can include various structures and feature, in order to stabilize diaphragm activated device 380 distal end 384.For example, in certain embodiments, barrier film 356 is arranged to include internal diameter 358, the size of the internal diameter 358 is set Into the external diameter of the distal end 384 of substantially equal to diaphragm activated device 380, as illustrated in figure 11A.In other embodiments, barrier film 356 is set It is set to inner annular ridge or projection 360, the internal diameter 358 of the inner annular ridge or projection 360 is sized to basic etc. External diameter in distal end 384, as shown in Figure 11 B.Therefore, in these embodiments, distal end 384 is by the radial support of barrier film 356.

With reference to figure 11C, in certain embodiments, the inner surface 376 of barrier film 356 is changing into including one or more undulation portions Divide (relief) 391.In certain embodiments, relief part 391 includes the annular notch of spill, and the annular notch is arranged to connect Positive classification 392 is received, the positive classification 392 includes a part for the distal end 384 of diaphragm activated device 380.In other embodiments, Relief part 391 includes single indenture, the feature 392 for being sized and configured to receive diaphragm activated device 380 of the indenture.Also Have, in other embodiments, relief part 391 includes positive classification, and feature 392 includes negative or recessed features and (do not shown Go out).Therefore, in certain embodiments, the interaction between relief part 391 and feature 392 provides diaphragm activated device 380 radial support in catheter adapter 314 and axially retain.This structure can need not add holding feature, such as Clip and retention groove.

Below with reference to Figure 11 D, barrier film 356 includes cheese type face 394, so as to offset take out inducting device syringe needle 350 it The after-applied pressure on the distal side 386 of barrier film 356.Cheese type face 394 provides additional strong to the distal side 386 of barrier film 356 Degree, so as to add the required Fluid pressure so that barrier film 356 fails.In certain embodiments, when blood reaches barrier film 356 When, due to flowing into the pressure of the blood in forward chamber 362, cheese type face 394 helps barrier film 356 to close.In other implementations In example, barrier film 356 includes general flat type face, as shown in Fig. 5 A, 5B and 7 to 11C, or can include flat and bending table The combination (not shown) in face.

Below with reference to Figure 12, conduit tube component 300 is illustrated in figure after barrier film 356 is driven by diaphragm activated device 380 Sectional view.When in the proximal open 326 that connector 342 inserts catheter adapter 314, the probe portion 346 of connector 342 Contacted with the contact surface 340 of diaphragm activated device 380.When connector 342 is further inserted into proximal open 326, barrier film Therefore actuator 380 advances along distal direction 390, moved to so that rinsing fin 320 in conversion groove 368.Work as connector 342 when being advanced further to proximal open 326, the searching surface 348 of diaphragm activated device 380 by barrier film 356 slit 366.Therefore, the searching surface 348 of diaphragm activated device 380 is located in forward chamber 362, so as to provide through barrier film 356 Fluid passage.

Below with reference to Figure 13 to 20, a variety of valves according to some embodiments are illustrated in figure, the purpose of these valves is into one Step is eliminated or reduced produces region relatively low or without flow of fluid in vascular access device, and the vascular access device includes valve machine Structure, the valve system include barrier film and diaphragm activated device or pusher.

Figure 13 and 14 illustrates embodiments of the invention, wherein, sleeve 45 enters as relatively low or nothing for anti-fluid flow In any void space of fluid flow region.

Figure 13 illustrates barrier film 43, and the barrier film 43 forms fluid after syringe needle is taken out in the tube chamber 341 of catheter body 41 Sealing, wherein diaphragm activated device or pusher 344 are in proximal position.Sleeve 45 is installed around pusher 344, to be formed Fluid Sealing between the periphery 53 of the portions of proximal 348 of pusher 344 and the inner surface 354 of tube chamber 341.Therefore, fluid is not It can be flowed between the near-end of pusher 344 and the inner surface 354 of tube chamber 341 in void space 498.Figure 14 is illustrated in remote Pusher 344 in side position, wherein, fluid can only be flowed by the tube chamber 51 of pusher 344.Sleeve 45 is also maintained at promotion Fluid Sealing between the periphery 53 of device 344 and the inner surface 54 of tube chamber 341.Therefore, fluid cannot flow into void space 498 In.In addition, when pusher 344 is in distal position, the conical outer surface 351 of the distal part of sleeve 45 reduces space sky Between 498 size.Sleeve 45 is manufactured by softer elastomeric material, such as liquid silastic, and by suitable mold treatment and On pusher 344, such as by inserting the group of molding, injection-molded and other molding techniques or molding technique Close.

Figure 15 and 16 illustrates the another embodiment of the present invention with valve system, and the valve system use promotees in tubular barrier film Seal at the near-end 65 of dynamic device 365 and distal end 75, the pipe in actuator 365 and catheter body 61 is entered so as to anti-fluid flow In void space 698 and 699 between the inner surface 74 of chamber 363.Distal seal 75 is included in barrier film 63, so as to when promotion Device prevents any fluid in actuator 365 when being in proximal position (as shown in Figure 15) or distal position (as shown in Figure 16) Distal end and barrier film 63 proximal face between flow.Proximal seal 65 is the company of the periphery for the near-end for surrounding actuator 365 Continuous anchor ring or endless belt, in nearside and distal side activation point, the continuous anchor ring or endless belt and the tube chamber 363 of catheter body 61 Inner surface 74 forms Fluid Sealing.Proximal seal 65 is manufactured by softer elastomeric material, such as liquid silastic, and is covered Cover mold system (over-molded) on actuator 365 and by the antelabium 367 on the outer surface of the near-end of actuator 365 and It is held in place.Actuator 365 has multiple fins 369, and these fins 369 stretch out from outer surface 371, and around the outer surface 371 Periphery be uniformly distributed.These long enoughs of fin 369, to contact a part 73 for the inner surface 74 of tube chamber 363, and for leading to Cross and contacted along distal direction with barrier film 63 and contacted along proximal direction with the indenture or step 378 of inner surface 74 and limit actuator 365 along catheter body motion.

Figure 17 to 20 illustrates some embodiments with valve system, and the valve system is arranged to exclude less restriction space Space, so as to eliminate the region of no flow of fluid to the region of relatively low flow of fluid.

Figure 17 and 18 illustrates the embodiment that barrier film 83 encases the major part of actuator 383.Actuator 383 includes head Partly, barrel portion and plunger.Plunger 381 is located at the proximal end of actuator 383, and the diameter of the plunger 381 is at least equal to conduit The diameter of the tube chamber 385 of body 81, so, fluid can not pass through between inner surface 94 and plunger 80.The external diameter edge of barrier film 83 Its whole length and does not have between barrier film 83 and the inner surface 94 of tube chamber 385 space empty at least equal to the diameter of tube chamber 82 Between.In addition, barrier film 83 has tube chamber 85, the internal diameter of the tube chamber 85 is equal to the external diameter of the barrel portion 87 of actuator 383, so as to be formed Along the additive fluid seal of the length of barrel portion 87.Moreover, the relative length of actuator 383 and barrier film 83 is so, i.e., When actuator 383 is in distal position, the distal surface 389 of plunger 381 is in close contact with the near-end 388 of barrier film 83.Therefore, There is no void space between plunger 381 and barrier film 83.Head portion is located at the far-end of actuator 383, and is included in tube chamber Longitudinal slit 387 in 91 side wall, to allow fluid stream to be diverted to outside the tube chamber 91 of actuator 383, and reduce in interior table Around possibility distal surface, without flow region or relatively low flow region 393 of barrier film 83 at face 74.

Figure 19 and 20 illustrates a further embodiment of valve system, wherein, barrier film 103 includes：Barrel portion 107, this is tubular There is distal end 108 part 107；And film portion 109, the film portion 109 have the nearside flat surface at near-end 105.Every The barrel portion 107 of film 103 is arranged substantially in barrier film housing 111, and the convex shoulder by being formed in the surface of tube chamber 385 or Annular notch 121 and prevent distal motion.Fluid seal is formed at the periphery of film portion 109 and the nearside of tube chamber 385 Between the inner surface 114 of part 110, to prevent fluid from being leaked by barrier film 103 when the valves are closed.In certain embodiments, Barrier film 103 also include positioned at film portion 109 about at center through the film portion 109 extension syringe needle slit 113 or Valve opening, in order to penetrate barrier film 103 by inducting device syringe needle 5.Diaphragm activated device 304 is located in the portions of proximal of tube chamber 385, and Including barrel portion 115.In certain embodiments, tubular or sleeve part 115 is additionally included in multiple longitudinal slits in side wall Or flow channel 116, these longitudinal slits or flow channel 116 are uniformly distributed around the periphery of barrel portion 115, and positioned at remote At end or drive end 117, so, gap is formed between drive end 117 and film 109.

Figure 19 illustrates the diaphragm activated device 304 that proximal position is in after inducting device syringe needle 5 is taken out.Particularly, every The drive end 117 of film actuator 304 is located against the nearside flat surface of the film portion 109 of barrier film 103, has a common boundary to be formed Face.Diameter of the tube chamber 385 in portions of proximal 310 is approximately equal to (such as the luer connection of connector 106 of vascular access device Device), the external diameter of diaphragm activated device 304 and film portion 109, so, in connector 106 (as shown in Figure 20), diaphragm activated There is no void space between the contact jaw and film portion 109 of device 304.The inner surface 114 and portions of proximal of first tube chamber 385 310 are further sealed by film portion 109.

Below with reference to Figure 20, diaphragm activated device 304 is illustrated in figure and is in distal position, therefore, connector 106 is along distal side Diaphragm activated device 304 is repositioned forward in direction, so that the drive end 117 of diaphragm activated device 304 becomes film portion 109 Shape.The deformation results in fluid passage, and therefore, fluid bypasses film portion 109 by slit 116, then in film portion Flowed between 109 periphery and inner surface 114, and guide and pass through the opening 118 in the side wall of barrel portion 107.Around thin This diverter fluid path on the periphery of film part 109 causes the fluid stream of turbulent flow, and the fluid stream of the turbulent flow is reduced in tube chamber Convex shoulder 119 in 385 nearby produces the possibility of viscous flow or relatively low flow region.Then, fluid continues along barrel portion 107 Internal diameter flows, and flows into the distal part 112 of tube chamber 385.

Any barrier film described here can be made up of a variety of suitable materials of a variety of suitable manufacture methods.Example Such as, barrier film can be formed by liquid silastic by suitable molding process, for example, insertion molding, it is injection-molded or The combination of other molding techniques or molding technique.Barrier film 103 or any barrier film described here are additionally may included in any of it Antibacterial material coating on surface, these surfaces particularly contacted with fluid.

The feelings described in broad sense here with claimed hereinafter, of the invention structure, method or other essential characteristics are not being departed from Under condition, the present invention can be implemented in other specific forms.The embodiment will be considered to simply illustrate, and be not limit It is fixed.Therefore, the scope of the present invention is represented by accessory claim, rather than aforementioned specification.In the equivalent meaning of claim All changes in think of and scope all will be contained in their scope.

Claims (10)

1. a kind of vascular access device, the vascular access device includes：

Body, the body have the first tube chamber extended through it；

Barrier film, the barrier film are arranged in first tube chamber, so as to which the first tube chamber is divided into portions of proximal and distal part, barrier film The first fluid seal formed between portions of proximal and distal part, barrier film, which also has, is arranged in the portions of proximal and distal portion / the valve that fails；

Pusher, the pusher are arranged in the portions of proximal of the first tube chamber, and second fluid seal is arranged in the outer of pusher Between the inner wall surface of surface and the first tube chamber, pusher also has near-end, distal end and the second tube chamber extended between them, Wherein, by the distal advancement of pusher fluid is provided portions of proximal and distal part and connected through can fails valve Logical, so, the second tube chamber provides the pipeline between the portions of proximal and distal part of the first tube chamber,

Wherein, the pusher includes being used to guide fluid stream or turns to fluid stream and be allowed to surround and/or by described The features of pusher, the features include flow deflector and flowing turns to conduit, and the flow deflector includes described The inwardly inclined portion of the outer surface of pusher and outward-dipping part.

2. vascular access device according to claim 1, wherein：The pusher can be along first tube chamber proximally position Put and move to distal position.

3. vascular access device according to claim 1, wherein：The second fluid seal prevents fluid from being pushed away described Pass through between the outer surface of dynamic device and the inner surface of first tube chamber.

4. vascular access device according to claim 1, wherein：Fluid can be by the pipeline and in the described first pipe Flowed between the portions of proximal and distal part of chamber.

5. vascular access device according to claim 1, wherein：The second fluid seal includes being arranged in described push away Sleeve on the outer surface of dynamic device.

6. vascular access device according to claim 1, wherein：The vascular access device is conduit.

7. vascular access device according to claim 1, in addition to：It is arranged in the outer surface and described of pusher Void space between the inner wall surface of one tube chamber, the second fluid seal prevent the fluid from entering the space Space.

8. a kind of vascular access device, the vascular access device includes：

Body, the body have the first tube chamber extended through it；And

Flow control valve, the flow control valve are arranged in first tube chamber, and the flow control valve includes：Barrier film, should be every Film has path；Pusher, the pusher are arranged in first tube chamber and close to the barrier films, the pusher have distal end, Near-end and the second tube chamber through it, the pusher also have seal, and the seal is arranged on the outer surface of the pusher On, Fluid Sealing that the seal is formed between the outer surface of the pusher and the inner surface of first tube chamber, First tube chamber and the second tube chamber almost coaxial alignment, and the seal is arranged in first tube chamber and the second pipe Between chamber, to form the Fluid Sealing,

Wherein, the pusher includes being used to guide fluid stream or turns to fluid stream and be allowed to surround and/or by described The features of pusher, the features include flow deflector and flowing turns to conduit, and the flow deflector includes described The inwardly inclined portion of the outer surface of pusher and outward-dipping part.

9. vascular access device according to claim 8, wherein：The pusher can be along first tube chamber proximally position Put and move to distal position.

10. vascular access device according to claim 9, wherein：When the pusher is in the distal position, institute State the distal end bias of pusher and pass through the pipe of the barrier film through the path of the barrier film, second segment dislocation Road.